Trial Information

A Phase II Study of Allografting to Establish Mixed or Full Donor Chimerism as Consolidative Immunotherapy for Older Patients With AML in Complete Remission Using Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil

OBJECTIVES: I. Determine whether mixed or full donor chimerism can be safely established in
older patients with acute myeloid leukemia (AML) treated with nonmyeloablative conditioning
comprised of low dose total body irradiation, followed by allogeneic peripheral blood stem
cell transplantation, followed by unrelated donor lymphocyte infusion (DLI). II. Determine
whether mixed chimerism can be safely converted to full donor chimerism in patients treated
with DLI. III. Determine the potential efficacy of this regimen in AML patients who are in
first remission.

OUTLINE: Conditioning: Patients undergo low dose total body irradiation followed by infusion
of allogeneic peripheral blood stem cells (PBSC) on day 0. Donor lymphocyte infusions:
Nonmobilized donor lymphocytes are harvested from the same HLA identical related donor on
day 95 after PBSC transplantation. Eligible patients with mixed chimerism and no graft
versus host disease (GVHD) receive the first donor lymphocyte infusion (DLI) on the same day
that donor lymphocytes are collected. Patients who continue to have mixed chimerism and no
GVHD receive the second DLI at a higher dose level on day 65 after the first DLI. Patients
are followed weekly until day 90, and then monthly thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.